Wednesday, October 20, 2010

admittedly we were wrong.

You are one lucky individual to witness this historic event. Although they never actually used the words "we were wrong," the FDA has also never revoked approval on a product they had already pushed to the market. 

Menaflex, a knee patch by ReGen Biologics, was FDA approved in 2008. The product had already been thriving in Europe for several years and administered to over 3,000 knee implant patients. Thus the FDA was inclined to push the product without thoroughly testing the device. 

"We are concluding that the science does not support a decision to clear the device, and therefore we’ll move forward to rescind” its approval, Dr. Jeffrey E. Shuren, director of the FDA’s device center reported.

The FDA has never admitted they were wrong for approving a drug or medical product. They also never rescinded approval two years after a product has circulated in the market. But pressures from a group of FDA medical officials caused the FDA to revisit the approval. They argued that politics unmistakably trumped the science. 

But honestly, I could care less about the knee patch. I am worried about all the other drugs that are currently on the market because they were approved out of "politics."  When political pressures sets in I want to know that the FDA is still holding its ground and not succumbing to the harassment. 

I recently saw a documentary by PBS Frontline on the emergence of AIDS. With the initial discovery of AIDS politicians were reluctant to spearhead campaigns to fight AIDS and encourage patient education due to the stigma attached to the illness. And when drug companies began finding antiretroviral drugs, ART, to combat against the HIV virus that caused AIDS, the FDA was under immense pressure to approve the drug. When millions of people are dying from an incurable virus the FDA better not let "politics" be a determining factor for drug approval. I wouldn't want millions more to die because politics trumped science. 

There is too much at stake. 

-J

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